An exploratory, open-label, randomized, 2 treatments, 2 periods, 2 sequences crossover study to assess the pharmacokinetics of two FT218 batches (single dose administered at the dose of 6g) in healthy volunteers

Completed

• Conditions: Narcolepsy; sleep / wake disorder; 10040998

• Registration Number: NL-OMON45837
• Lead Sponsor: Flamel Ireland Ltd trading under the business name Avadel Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- healthy male and female subjects
- 20-50 yrs, inclusive
- BMI: 18.0-28.0 kg / m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study. Donation or loss of more than 100 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the first study drug administration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Plasma PK parameters of gamma-hydroxybutyric acid (GHB) estimated using<br /><br>noncompartmental analysis, as appropriate: Cmax, tmax, kel, t1/2, AUC0-8h,<br /><br>AUC0-t, AUC0-inf, AUC%extra, C8h. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse events, physical examinations, vital signs, pulse oximetry, 12-lead<br /><br>electrocardiogram, and clinical laboratory tests.</p><br>